The primary goal of the Protocol Review and Monitoring Committee (PRMC) is to ensure that all cancerrelated clinical research studies involving human subjects that are conducted within Washington University Medical Center are scientifically evaluated and prioritized by the Siteman Cancer Center (SCC), Studies that do not have prior NCI review (institutional and industry-initiated studies) are reviewed by the full PRMC to ensure that they are (1) scientifically and statistically sound, (2) appropriately designed, (3) feasible for completion, (4) prioritized by the appropriate research working group(s), and (5) in compliance with NIH guidelines for clinical trials, including monitoring for accrual and undue toxicity (if applicable). Studies that have received prior NCI review (primarily cooperative group studies) are reviewed administratively (by PRMC Co-Chairs) to ensure that they have been prioritized by the appropriate research working group(s), and that all SCC guidelines have been addressed, as appropriate. For the purposes of this committee, a cancer research study is defined as a formal research plan that: (1) is intended to evaluate an untested, unproven or unknown regimen or procedure for the screening, diagnosis, staging, treatment, support, outcome, prevention, control, or characterization of human subjects in regard to cancer, or compares standard to unproven regimens or procedures, and (2) requires the approval ofthe Institutional Review Board (IRB). The PRMC is responsible for: Providing scientific peer-review for all investigator- and industry-initiated cancer research studies. Reviewing all active cancer research studies for renewal/termination (the Quality Assurance and Safety Monitoring Committee can independently close studies but report findings to the PRMC). Ensuring that all competing studies have been prioritized by the leadership ofthe appropriate research working group(s). Monitoring accrual in all active cancer research studies. Tracking and reporting information about study design and execution.